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Helixgate

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Opinion: STAT+: The real work for making dramatic gains against pancreatic cancer is just beginning

On May 31, at the American Society of Clinical Oncology (ASCO) meeting in Chicago, an international study co-led by a UCLA research team reported that patients with pancreatic cancer who took the drug daraxonrasib lived substantially longer, for an average of 13.2 months, compared with 6.6 to 6.7 months for patients who had chemotherapy alone.

This is welcome news, and in anticipation of these results, the FDA, just a month earlier, announced it was granting early access to the drug for selected patients who had failed guideline-directed treatments for this lethal malignancy. 

Widespread media coverage of this regulatory pivot in drug access highlights the intense, enduring interest among the general public, as well as in the scientific and medical communities, for identifying treatments that can move the survival needle lethal for complex, heterogeneous malignancies, thereby derailing effective treatment, especially when only single drugs are deployed to improve clinical outcomes.

Continue to STAT+ to read the full story…

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On May 31, at the American Society of Clinical Oncology (ASCO) meeting in Chicago, an international study co-led by a UCLA research team reported that patients with pancreatic cancer who took the drug daraxonrasib lived substantially longer, for an average of 13.2 months, compared with 6.6 to 6.7 months for patients who had chemotherapy alone.

This is welcome news, and in anticipation of these results, the FDA, just a month earlier, announced it was granting early access to the drug for selected patients who had failed guideline-directed treatments for this lethal malignancy. 

Widespread media coverage of this regulatory pivot in drug access highlights the intense, enduring interest among the general public, as well as in the scientific and medical communities, for identifying treatments that can move the survival needle lethal for complex, heterogeneous malignancies, thereby derailing effective treatment, especially when only single drugs are deployed to improve clinical outcomes.

Continue to STAT+ to read the full story…

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Denali sells FDA voucher for $195M to support neurodegenerative pipeline

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Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.

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US launches investigation into German drug pricing, citing unfair R&D burden

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The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.

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STAT+: Up and down the ladder: The latest comings and goings

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Protego Biopharma hired Jae Kim as chief medical officer. Previously, he held the same roles at Septerna and Design Therapeutics.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Protego Biopharma hired Jae Kim as chief medical officer. Previously, he held the same roles at Septerna and Design Therapeutics.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

Read More

Continue Reading
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